A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

NCT05632770 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00015632R01MH130460
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

Conditions

PTSD; Physical Injury

Keywords

PTSD; Physical Injury; Emergency Department Utilization

Outcome Measures

Primary Outcomes (2)

• Posttraumatic Stress Disorder (PTSD) symptoms change over time

  The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

• Emergency department utilization change over time

  Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.

  Baseline injury admission to 12-months post-injury follow-up

Secondary Outcomes (5)

• Alcohol use change over time

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

• Mental and physical functioning change over time

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

• Depression symptoms change over time

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

• Suicide risk assessment change over time

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

• Substance use change over time

  Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

Study Arms (2)

Stepped Collaborative Care (Intervention)

EXPERIMENTAL

Patients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity.

Behavioral: Stepped Collaborative Care

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

ACTIVE COMPARATOR

Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral.

Behavioral: American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

Interventions

Stepped Collaborative Care BEHAVIORAL

Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.

Stepped Collaborative Care (Intervention)

American College of Surgeons (ACS) Required Screening and Referral (Usual Care) BEHAVIORAL

The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Injured patients ≥18 years of age
• Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen
• Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) .
• Speak English and/or Spanish

You may not qualify if:

• Age \<18
• Not admitted for a traumatic injury
• Speak a language other than English and/or Spanish
• Acutely suicidal/admitted for a suicide attempt
• Cognitively impaired
• Incarcerated
• Acutely psychotic
• Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada
• Less than 2 pieces of contact information
• Prior history of violence, such that study staff may not be safe
• Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition
• Most recent COVID-19 test positive

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Knutzen T, Bulger E, Iles-Shih M, Hernandez A, Engstrom A, Whiteside L, Birk N, Abu K, Shoyer J, Conde C, Ryan P, Wang J, Russo J, Heagerty P, Palinkas L, Zatzick D. Stepped collaborative care versus American College of Surgeons Committee on Trauma required screening and referral for posttraumatic stress disorder: Clinical trial protocol. Contemp Clin Trials. 2024 Jan;136:107380. doi: 10.1016/j.cct.2023.107380. Epub 2023 Nov 10.

  PMID: 37952714 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Douglas Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 1, 2022
• Study Start: January 9, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-03

Locations

US (1)